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This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.
This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).
A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant Arm | Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT | ||
| Control Arm | Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination | This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study. | one year prior to alloHCT to within 18 months after alloHCT |
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Inclusion Criteria:
Exclusion Criteria:
• Patients without consent for research.
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The study population will include a minimum of 50 patients with CTCL or ATLL who received mogamulizumab within one year prior to alloHCT. At least 40 patients should have been diagnosed with CTCL and at least 33 patients should have received mogamulizumab as last therapy line before alloHCT. Data will be collected from no more than 100 controls with similar characteristics to the mogamulizumab-treated patients, and who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT. Information on patients receiving mogamulizumab within 18 months after alloHCT will also be collected.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda J Burns, MD | Contact | 414-805-0714 | lburns@mcw.edu | |
| Jatin Jadwani, BDS, MSc Clinical Research | Contact | +49 15114861167 | jatin.jadwani@kyowakirin.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIBMTR | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D015459 | Leukemia-Lymphoma, Adult T-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |